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Merck Abandons Plans to Seek FDA Approval of Cholesterol Drug

Merck is pulling the plug on a cholesterol-lowering drug that met its main goal in a clinical trial but still raised questions about whether it would benefit patients.

Kenilworth, NJ-based Merck (NYSE: MRK) said Wednesday that it won’t seek regulatory approval for anacetrapib, a drug that inhibits a protein called cholesterolylester transfer protein (CETP). By blocking this protein, the drug was intended to raise levels of HDL—the “good” cholesterol. But CETP inhibitors as a drug class have fared poorly. Such drugs from Pfizer (NYSE: PFE), Roche, and Eli Lilly (NYSE: LLY) all failed in large clinical trials, and in some patients, produced serious side effects such as high blood pressure.

In August, Merck released results from a four-year, 30,499-patient clinical trial that showed the drug reduced the risk of major coronary events, such as heart attacks. Those results raised some hope that anacetrapib could challenge a new class of cholesterol-lowering medicines called PCSK9 inhibitors, which reduce the “bad” LDL cholesterol . But Merck also said the results showed that the drug accumulates in the body’s fat tissue after prolonged dosing, which can affect the distribution of a drug within the body. The drug was already linked to potential side effects on the kidneys, as well as higher blood pressure. Merck deferred a decision about the drug until it could study the results more closely.

Merck now says its review, which included discussions with external experts, concluded that the drug can’t go any further. In a brief prepared statement that does not elaborate on the company’s conclusions, Roger Perlmutter, president of Merck Research Laboratories, said that “the clinical profile for anacetrapib does not support regulatory filings.”

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Frank Vinluan is editor of Xconomy Raleigh-Durham, based in Research Triangle Park. You can reach him at fvinluan [at] xconomy.com Follow @frankvinluan